STA-4783/Paclitaxel or Paclitaxel Alone in Melanoma

Synta Pharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Melanoma

Treatments

Drug: Paclitaxel

Drug: STA-4783

Study type

Interventional

Funder types

Industry

Identifiers

NCT00084214

4783-03

Details and patient eligibility

About

This study is designed to assess the efficacy of a weekly treatment regimen of STA-4783 and paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma patients.

Full description

STA-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. In an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. When paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. There is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

M or F 18 or older with histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
ECOG performance status of greater than or equal to 2
Measurable disease per RECIST criteria
Received no more than 1 regimen of prior chemotherapy (unlimited immunotherapy regimens are allowed)
At least 4 weeks have passed since last chemotherapy or immunotherapy
At least 2 weeks have passed since last radiotherapy.
Life expectancy of greater than 12 weeks
Clinical lab values within protocol parameters

Exclusion criteria

Female patients pregnant or lactating
Female patients of childbearing potential not using or not willing to use effective contraception
Presence of a second malignancy other than nonmelanoma skin cancer
Presence of a clinically significant and uncontrolled infection
Presence of clinically significant arrythmias
Presence of serious concurrent illness or other conditions that do not permit adequate follow-up and compliance with protocol
History of severe hypersensitivity reactions to taxanes
Use of any investigational agents within 4 weeks prior to the first dose of study drug